Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-03-07FDA-DeviceBaxter Healthcare CorporationClass IISterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105
Affected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
- 2018-03-07FDA-DeviceConMed CorporationClass IISTAT 2¿ I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and Extension Sets (Catalog Numbers: (1) S2-12 N, STAT 2¿ Extension Set Gravity Flow Controller (Needle-Free), 12 length, (2) S2V-20 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 20 Drops/ml, 84 length, and (3) S2V-60 N, STAT 2¿ Primary Administration Set Gravity Flow Controller (Needle-Free), 60 Drops/ml, 84 length) The STAT 2¿ Extension sets are for use in conjunction with commonly a
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
- 2018-03-07FDA-DeviceConMed CorporationClass IISTAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2¿ I.V. Controller, (2) S2-12, STAT 2¿ Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2¿ Secondary Set Gravity Flow Controller, 20 Drops/ml, 13 length, (4) S2V-20, STAT 2¿ Primary Administration Set Gravity Flow Controller, 20 Drops/ml, 84 length, and (5) S2V-60, STAT 2¿ Primary Administration Set Gravity Flow Controller, 60 Drops/ml,
Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates.
- 2018-03-07FDA-DeviceZimmer Biomet, Inc.Class IIThe 2nd Assist Knee Positioner
Zimmer Biomet is conducting a medical device recall for the 2nd Assistant Knee Positioner due to the potential for the sterile packaging barrier to be breached during distribution.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom SPINE convenience kits, Item Code: LITT016-04
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAvid Medical, Inc.Class IIAVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
- 2018-03-07FDA-DeviceAlcon Research, LTD.Class IICustom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a component.) Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
- 2018-03-07FDA-DeviceAlcon Research, LTD.Class IIAlcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.
- 2018-03-07FDA-Device3M Company - Health Care BusinessClass II3M Surgical Clipper Professional 9681
Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy.
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